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510(k) K761000

PAP-TRAY I (CATALOG #C600-1) by Lerner Laboratories, Inc. — Product Code LEA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1976
Date Received
November 8, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Preservative, Cytological
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Lerner Laboratories, Inc.

  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K854083 — XYLENE SUBSTITUTE MONTANT (October 22, 1985)
  • K821443 — FORMICAL (June 2, 1982)
  • K761001 — PAP-TRAY II (CATALOG #C600-2) (December 6, 1976)

Other clearances for product code LEA

  • K873594 — TIF FECAL TEST (September 29, 1987)
  • K770592 — CYTOLOGY FIXATIVE (May 20, 1977)
  • K761001 — PAP-TRAY II (CATALOG #C600-2) (December 6, 1976)